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FDA 510(k)

DIFFERENTIAL COUNTING BOARD

K-Number: K915071 · 1992-01-17

ApplicantBiovation, Inc.
Decision Date1992-01-17
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIFFERENTIAL COUNTING BOARD is the device name listed in this FDA 510(k) record. The listed applicant is Biovation, Inc.. It received FDA 510(k) clearance on 1992-01-17 under 510(k) number K915071. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIFFERENTIAL COUNTING BOARD?

DIFFERENTIAL COUNTING BOARD is a medical device that received FDA 510(k) clearance on 1992-01-17. The listed applicant is Biovation, Inc.. The 510(k) number is K915071.

When did DIFFERENTIAL COUNTING BOARD receive FDA 510(k) clearance?

DIFFERENTIAL COUNTING BOARD received FDA 510(k) clearance on 1992-01-17, under 510(k) number K915071.

Who is the listed applicant for DIFFERENTIAL COUNTING BOARD?

The FDA 510(k) record lists Biovation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIFFERENTIAL COUNTING BOARD?

The FDA product code for DIFFERENTIAL COUNTING BOARD is GKZ.

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Other records listing Biovation, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K925528BIOVATION K-MANAGERK923844LYRIS 100/120 LABORATORY INFORMATION SYSTEMK853026BIOVATION MAX DATA MANAGEMENT SYSTEMK842401CHEMISTRY CONSOLEK831830LYRIS MODULAR INFO SYSTEMK821534HEMATOLOGY DATA MANAGEMENT SYS

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Related Devices (Code: GKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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